- Amgen (Holly Springs, NC)
- …central utilities and office space. Amgen is targeting 2024 for site completion. Senior Manager Quality Control Support **What you will do** Let's do this. Let's ... use our unique contributions to serve patients. The Senior Manager Quality Control Support we seek is...tech transfer projects + Expertise in global regulatory requirements ( FDA , EMA, etc.) + Strong background in laboratory compliance,… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP ... working closely with cross-functional teams to enhance manufacturing processes, quality management, and overall system integration. **Strategic Solution Architecture… more
- ITW (Washington, NC)
- …to identify effective solutions for scrap reduction. Compliance/Certification + Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, ... **Job Description:** **GENERAL ACCOUNTABILITY:** This position reports to ITW Medical's Director, Quality Assurance & Regulatory and is responsible for Quality … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and regions. **Summary:** Responsible for managing all aspects (ie quality systems, documentation, laboratory operations, compliance, training, staffing and ... budgetary needs, etc.) of the Quality Control (QC) Environmental Monitoring laboratory. **Primary responsibilities for role:** + Manages all aspects of a Quality … more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... you're passionate about pharmacovigilance! You are a team player who loves quality , compliance, finding solutions and ensuring training standards are implemented and… more
- Biomat USA, Inc. (Kannapolis, NC)
- …and services in more than 110 countries and regions. **Acknowledgment** : The Operations Manager is a key member of the donor center leadership team, responsible for ... of the center. Acts on behalf of the Center Manager in his/her absence, may manage the center alone... is not present. + Collaborates with Training and Quality staff to ensure that training and quality… more
- Biomat USA, Inc. (Greenville, NC)
- …order. + Identifies regulatory deficiencies and in collaboration with the Center Quality Manager implements immediate corrective action. + Minimize center ... than 110 countries and regions. Acts as the general manager for a Plasma Collection Center and has overall...the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... plan, execute, and supervise study oversight activities with guidance from Quality , Strategic Development Clinical Operations, and clinical execution team. Oversee… more
- Lilly (Concord, NC)
- …now is the perfect opportunity! During the project phase, the Senior Manager , Parenteral Operations (Nights) is responsible for supporting staffing, training, and ... sites. Once the facility is turned over to operations, the Senior Manager , Parenteral Operations (Nights) will support meeting annual production goals. The Senior… more
- US Tech Solutions (Wilson, NC)
- …the system as appropriate. + Generate reports from the system as directed by the Quality Systems Manager + Develop and apply systems and procedures related to ... Good Documentation Practice (GDocP) and GMP to site personnel as directed by the Quality Systems Manager + Assist BioNC Learning & Development department the… more